The purpose of this study is to evaluate the effect of food on the single-dose pharmacokinetics (PK) of alisertib administered as an enteric-coated tablet (ECT) formulation in participants with advanced solid tumors or lymphomas.
The drug being tested in this study is called alisertib. Alisertib is being tested in adult participants with advanced solid tumors or lymphomas. The study enrolled 26 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Alisertib 50 mg Fed + Fasted * Alisertib 50 mg Fasted + Fed All participants will be asked to take one alisertib tablet (ECT), orally, with or without a standard high-fat breakfast Cycle 1, Day 1, with the respective alternate food intake condition (fasted to fed or fed to fasted) on Cycle 2, Day 1, each followed by 14-day rest period. Participants will take alisertib, ECT, orally BID on Days 4 to 10 of Cycles 1 and 2, each followed by 14-day rest period. From Cycle 3 onwards participants will continue taking alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity. This multi-center trial conducted at 3 sites in the United States. Participants will make multiple visits to the clinic and plus a final visit after 30 days of receiving their last dose of drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Alisertib ECT
Unnamed facility
The Bronx, New York, United States
Unnamed facility
Nashville, Tennessee, United States
Unnamed facility
San Antonio, Texas, United States
Cmax: Maximum Observed Plasma Concentration of Alisertib
Time frame: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib
Time frame: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib
Time frame: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time frame: From first dose through 30 days after the last dose of study drug (up to 225 days)
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
The number of participants with any clinical significant change in safety laboratory values collected throughout the study.
Time frame: From first dose through 30 days after the last dose of study drug (up to 225 days)
Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs
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The number of participants with any clinical significant change in vital signs (sitting diastolic and systolic blood pressure, heart rate, and temperature) were collected throughout the study.
Time frame: From first dose through 30 days after the last dose of study drug (up to 225 days)